Cleared Traditional

K864164 - CRIS ADAPTED WITH VOLUME LIMITING BAG

K864164 is an FDA 510(k) clearance for CRIS ADAPTED WITH VOLUME LIMITING BAG, manufactured by Y. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K864164 · Y · General Hospital
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Dec 1986
Decision
54d
Days
Class 2
Risk

K864164 is an FDA 510(k) clearance for the CRIS ADAPTED WITH VOLUME LIMITING BAG. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Y (San Diego, US). The FDA issued a Cleared decision on December 16, 1986 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Y devices

FDA 510(k) Submission Details - K864164

510(k) Number K864164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date December 16, 1986
Days to Decision 54 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 129d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 799
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K864164.
SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC.
K870940 · Travenol Laboratories, S.A. · Mar 1987
NORFOLK MEDICAL BUTTERFLY INFUSION SET
K870188 · Norfolk Medical Products, Inc. · Feb 1987
MANAN CONTRAST MEDIA ADMINISTRATION SET
K864405 · Manan Manufacturing Co., Inc. · Dec 1986
SECONDARY SET LOCK
K864338 · Travenol Laboratories, S.A. · Nov 1986
BAG SPIKE EXTENSION SET
K863814 · Med Fusion Systems, Inc. · Oct 1986
EXEL BUTTERFLY SCALP VEIN SET
K862491 · Exel Intl. · Aug 1986